Method of providing for the minimization of extravasation during arthroscopic surgery

ABSTRACT

The devices and methods shown provide for the minimization of extravasation during arthroscopic surgery. The extravasation minimization device allows a surgeon to drain excess fluids from the soft tissue surrounding the surgical field while also providing a stable surgical portal for arthroscopic surgical instruments.

This application is a continuation of U.S. patent application Ser. No.13/850,241, filed Mar. 25, 2013, now U.S. Pat. No. 9,233,236 which is acontinuation of 13/204,961, filed Aug. 8, 2011, which is a continuationof 12/542,844, filed Aug. 18, 2009, now U.S. Pat. No. 7,993,299 which isa continuation of U.S. patent application Ser. No. 11/213,645, filedAug. 19, 2005, now U.S. Pat. No. 7,575,565.

FIELD OF THE INVENTIONS

The inventions described below relate to the field arthroscopic surgeryand more specifically, to fluid management during arthroscopic shouldersurgery.

BACKGROUND OF THE INVENTIONS

During minimally invasive surgeries, surgical instruments such astrocars, cannulas, and optical medical devices, including endoscopes,cystoscopes, arthroscopes, laparoscopes, etc., are inserted throughsmall incisions or portals in a patient's body or body cavity andmanipulated to perform surgical procedures within the patient.

Minimally invasive surgical procedures are safer than open surgery andresult in quicker patient recovery, shorter hospital stays, and lowerhealth care costs. Accordingly, minimizing invasiveness continues to beof importance, and there is a continuing need for devices and methodsthat achieve this objective.

One area that has benefited from minimally invasive surgical techniquesis shoulder surgery. Shoulder surgery has evolved over the last severalyears from being an open surgical procedure to an arthroscopic surgicalprocedure. This evolution is the result of technological advances inequipment, instruments and implants.

During surgery, fluid is introduced into the surgical site to expand thejoint and control bleeding. A major concern involving arthroscopicsurgery of the shoulder is extravasation. Extravasation is thecollection of interstitial fluid such as blood, irrigation fluids ormedications into tissue surrounding an infusion site. Fluid escapinginto the soft tissues of the shoulder and the periscapular region canhave adverse effects on the patient. Some of these effects includetracheal compression, the accumulation of blood or clots in the joint(hemarthrosis), the forming of blood clots in veins (thrombophlebitis),arterial injury, nerve injury, the compression of blood vessels andnerves surrounding the joint (compartment syndrome), and infection.These effects cause longer recovery time as well as pain and discomfortin patients. Extravasation occurring during surgery can also causepremature collapse of the surgical field forcing surgeons to rushprocedures. Because of the effects caused by extravasation, devices andmethods are needed to reduce extravasation during arthroscopic shouldersurgery.

SUMMARY

The devices and methods shown below provide for the minimization offluid extravasation during arthroscopic surgery. The extravasationminimization device allows a surgeon to drain fluids from the softtissue surrounding the surgical field while also providing a stablesurgical portal for arthroscopic surgical instruments. The extravasationminimization device comprises a tube with outwardly extending ribsextending longitudinally along the tube having drainage lumens disposedtherein. Drainage holes in fluid communication with the drainage lumensare disposed in the channels running longitudinally between theoutwardly extending ribs. The proximal portion of the extravasationminimization device is provided with a fluid port, a manifold and othermeans of controlling the flow of fluid inside the extravasationminimization device. The distal tip of the atraumatic extravasationminimization device is arcuate in shape preventing damage to the tissuein the surgical field. Each drainage hole communicates with one or moreof the drainage lumens inside the ribs, thereby allowing fluid to flowbetween the surgical field and sources or sinks located outside thepatient. The extravasation minimization device allows the surgeon toreduce the amount of fluid extravasation occurring in surrounding tissuewhile preserving a surgical portal.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a method of performing arthroscopic surgery on apatient using the extravasation minimization device.

FIG. 2 is a side view of an extravasation minimization device.

FIG. 3 is a radial cross-sectional view of the extravasationminimization device.

FIG. 4 is a longitudinal sectional view of the extravasationminimization device in shoulder tissue.

FIG. 5 is an alternative configuration of the extravasation minimizationdevice.

FIG. 6 is a cross-sectional view of an extravasation minimization devicehaving drainage lumens provided within a sleeve.

FIG. 7 illustrates a detailed view of an extravasation minimizationdevice having fenestrations disposed about a cannula with exteriorgrooves.

FIG. 8 is a cross-sectional view of an extravasation minimization devicedisposed about a cannula with exterior grooves.

FIG. 9 is an extravasation minimization device having a “C” channelsleeve.

FIG. 10 is a radial cross-sectional view of the extravasationminimization device having a “C” channel sleeve.

FIG. 11 is an extravasation minimization device provided with one ormore strips of wicking material disposed about the outer surface of acannula.

FIG. 12 is a radial cross-sectional view of the extravasationminimization device provided with one or more strips of wicking materialdisposed about the outer surface of a cannula.

FIG. 13 is an extravasation minimization device with a retention tip anda slidable grommet.

DETAILED DESCRIPTION OF THE INVENTIONS

FIG. 1 illustrates a method of performing arthroscopic surgery on apatient's shoulder 1 using the extravasation minimization device 2. Theextravasation minimization device is shown inserted into the jointcapsule 3 of a shoulder of a patient. Various anatomical landmarks aredepicted including the patient's clavicle 4, scapula 5 and humerus 6. Anarthroscopic instrument 7 is disposed within the extravasationminimization device.

During arthroscopic shoulder surgery, the surgeon introduces thearthroscope into the shoulder via a first portal in order to visualizethe surgical field. A trimming instrument is introduced through a secondportal to remove or trim tissue that the surgeon determines should beremoved or trimmed. Optionally, an irrigating instrument may beintroduced through a third portal in order to distend the joint, and/orirrigate the surgical field to maintain a clear view.

FIG. 2 illustrates a side view of an extravasation minimization device 2while FIG. 3 is a cross-sectional view of the extravasation minimizationdevice 2. The extravasation minimization device 2 comprises a sleeve 8of resilient material having a central lumen 9 extending therethrough.The central lumen 9 is sized and dimensioned to accommodate cannulas andarthroscopic surgical instruments such as arthroscopes, endoscope, awl,pick, shaver, etc. The extravasation minimization device 2 furthercomprises a plurality of outwardly extending ribs 10 Extendinglongitudinally along the sleeve 8. Drainage lumens 11 are disposedwithin the ribs. A plurality or drainage apertures 12 is disposed inchannels 13 or flutes between the outwardly extending ribs 10. Thedrainage apertures 12 are in fluid communication with the drainagelumens 11 disposed within the ribs 10. The ribs 10 support tissue awayfrom the apertures 12 when the device is used during surgery. Theproximal portion of the extravasation minimization device is providedwith a manifold 14 or other adapter. The manifold or adapter providesfor the removal of fluid from the drainage lumens 11 through operableuse of a vacuum source or sink of wicking material. The manifold isplaced in fluid communication with the drainage lumens 11 and a fluidport 15. The fluid port is placed in fluid communication with a vacuumsource. The manifold 14 or fluid port 15 may be provided with or coupledto other means of controlling the flow of fluid and or the amount ofsuction inside the extravasation minimization device. The means forcontrolling suction and fluid flow may include valves, switches andcomputer based control systems. The distal tip 16 of the sleeve 8 isarcuate in shape preventing damage to tissue in the surgical field. Eachdrainage aperture 12 is in fluid communication with one or more of thedrainage lumens 11 disposed within the ribs 10, thereby allowing fluidto flow between the surgical field and vacuum sources or sinks locatedoutside the patient.

The extravasation minimization device may be manufactured fromsterilizable biocompatible polymers such as nylon, polycarbonateurethane, polyurethane, polydimethylsiloxane and polyethylene glycol. Asdepicted in the cross-sectional view in FIG. 3, the outward extendingribs 10 are provided with the drainage lumens. The longitudinal channels13 have an arcuate cross-section. Typically, the extravasationminimization device has an outer diameter of approximately 0.25 inches.The central lumen 9 is sized and dimensioned to accommodate the outerdiameter of arthroscopic surgical instruments. The sleeve friction fitsover the outer surface of the arthroscopic instrument when the sleeve 8is disposed about the arthroscopic instrument. Drainage apertures 12 influid communication with the drainage lumens 11 may also disposed alongthe inner diameter 17 of the central lumen of the extravasationminimization device.

FIG. 4 shows a sectional view of the extravasation minimization device 2in shoulder tissue. The device is disposed within a surgical portal 18created by a surgeon in a patient. The central lumen 9 allows theextravasation minimization device 2 to be disposed about an arthroscopiccannula device. During arthroscopic surgical procedures, pressurizedfluid is used to distend the joint, irrigate the surgical site anddisrupt tissue bleeding. The pressurized fluid, blood and debris 19 aredrained from shoulder tissue 20 surrounding the surgical site throughdrainage apertures. The device 2 drains excess fluid passing out of asurgical site into surrounding soft tissues in the shoulder. Removal offluid, blood and debris reduces the amount of fluid left in the shouldertissue thereby minimizing extravasation.

FIG. 5 depicts an alternative configuration of the extravasationminimization device 2 having an arthroscopic cannula 21 disposedtherein. Here, the extravasation minimization device 2 comprises asleeve 22 of wicking material such as medical grade open-cell foam,fabric, or felt. The foam, felt, or fabric can be manufactured frompolyolefin, polyurethane, polyester, silicone, expanded PTFE, nylon, orother suitable medical grade material. This sleeve 22 of wickingmaterial functions as a wick or conduit to channel excess pressurizedfluid into a proximal collection manifold 23 and away from the tissuesurrounding a surgical site. A fluid port 24 in fluid communication withthe manifold 23 allows fluid to flow to a vacuum source 30 or collectionsink outside the patient. The sleeve may also be manufactured from alaminate that provides both a non-stick outer surface and drainage ofexcess fluid through wicking or capillary action.

The extravasation minimization device absorbs fluid preferentiallyrelative to the surrounding muscle tissue. This prevents extravasation,the collection of interstitial fluid into the tissue. The extravasationminimization device can operate by capillary action or be used inconjunction with a vacuum source operably connected to a manifold oradapter coupled to the proximal end of the sleeve. The vacuum sourceremoves fluid from the wicking material preventing its saturation. Thesleeve is manufactured from material with sufficient stiffness toprevent collapse and occlusion.

As shown in FIG. 6, the sleeve 22 contains a central lumen 25 sized anddimension to friction fit over an arthroscopic shoulder cannula 21 orother surgical device. To aid in the transfer of fluid along the lengthof the wicking, drainage lumens 26 or channels running longitudinallymay be provided within the sleeve 22. These channels may alternativelybe formed by longitudinal grooves 27 in the outer surface of the cannula21 as shown in FIG. 7 and FIG. 8. The sleeve 22 may be manufactured froman open cell foam having a smooth exterior surface such as self-skinningfoam or be manufactured from a lamination construction of permeable andimpermeable layers. The laminate sleeve has an outer layer of non-stickmaterial comprising a thin polyester heat shrink tube allowing smoothentry into tissue while preventing adhesion to the tissue. A pluralityof fenestrations 28 in the outer layer of non-stick material allow thepassage of fluid from the soft tissue surrounding a surgical site toopen cell foam comprising an inner core of the self-skinning foam orlaminate. In addition to a friction fit configuration, the sleeve 22 canbe manufactured in a “C-clip” configuration as shown in FIGS. 9 and 10.Here, the radial cross section of the sleeve 22 of wicking material isin substantially the shape of a “C.” The sleeve is disposed about theouter surface of arthroscopic cannula 21 by using the longitudinal slit31 in the sleeve to place the cannula within the sleeve.

The extravasation minimization device 2 can be provided as one or morestrips of wicking material disposed about the outer surface of a cannula21. In FIG. 11 and FIG. 12, the outer surface of an arthroscopic cannulais provided with one or more longitudinal grooves 27 or flutes. Strips35 of wicking material are disposed within the grooves. The strips areplaced in fluid communication with a sink or vacuum source to preventthe wicking material from becoming saturated. A manifold or other fluidadapter disposed on the proximal end of the arthroscopic cannulaprovides for fluid communication between the wicking material and vacuumsource.

As illustrated in FIG. 13, the extravasation minimization device 2 canbe provided with a retention tip 37 and a sliding foam grommet 38. Here,the sleeve 22 of wicking material has a retention tip 37 at the distalend of the sleeve 22 having an outer diameter larger than the outerdiameter of the body of sleeve. The retention tip 37 can befrustoconical or arcuate in shape to facilitate entry into a surgicalportal while preventing injury to the patient. The retention tip 37creates a flange 39 that extends outward from the outer diameter of thesleeve 22. A slidable grommet 38 is tightly disposed about the outerdiameter of the sleeve 22. When in use, the sleeve 22 disposed about anarthroscopic cannula 21 is inserted into a surgical portal. Tissuesurrounding the portal can then be compressed between the flange 39 ofthe retention tip and the grommet 38 by sliding the grommet 38 down thesleeve. Compressing the tissue between the flange 39 and grommet forcesfluid out of the tissue and into the wicking material. Excess fluid isremoved from the sleeve 22 of wicking material using an adapter ormanifold 23 at the proximal end of the sleeve 22 in fluid communicationwith the sleeve 22. The adapter is operably connected to a vacuum sourceto drain fluid.

The extravasation minimization device 2 can be part of a complete fluidmanagement system comprising a fluid source, vacuum source, arthroscopicsurgical pump and control system. An over pressure valve can be operablycoupled to the extravasation minimization device 2 to allow a drainagelumen 26 in the device to open and drain the joint if the joint isover-pressurized by an arthroscopic pump.

While the preferred embodiments of the devices and methods have beendescribed in reference to the environment in which they were developed,they are merely illustrative of the principles of the inventions. Otherembodiments and configurations may be devised without departing from thespirit of the inventions and the scope of the appended claims.

I claim:
 1. A device for minimizing extravasation comprising: a sleeveof wicking material characterized by an outer diameter, a distal end anda proximal end, having a central lumen sized and dimensioned to beremovably disposed over an arthroscopic cannula; a flange disposed atthe sleeve distal end, wherein said flange has an outer diameter largerthan the sleeve outer diameter; an adapter disposed on the proximal endof the sleeve in fluid communication with the sleeve of wickingmaterial; and a grommet slidably disposed about the outer diameter ofthe sleeve between the adapter and the distal end; wherein the wickingmaterial permits excess fluid to be removed from tissue surrounding asurgical site.
 2. The device of claim 1 further comprising a vacuumsource in fluid communication with the adapter.
 3. The device of claim 1wherein the adapter is a manifold.
 4. The device of claim 1 wherein theflange is frustoconical in shape.
 5. The device of claim 1 wherein theflange is arcuate in shape.
 6. A method of performing arthroscopicsurgery, said method comprising the steps of: providing an extravasationminimization device, said device comprising: a sleeve of wickingmaterial characterized by an outer diameter, a distal end and a proximalend, having a central lumen sized and dimensioned to be removablydisposed over an arthroscopic cannula; a flange disposed at the sleevedistal end, wherein said flange has an outer diameter larger than thesleeve outer diameter; an adapter disposed on the proximal end of thesleeve in fluid communication with the sleeve of wicking material; and agrommet slidably disposed about the outer diameter of the sleeve betweenthe adapter and the distal end; wherein the wicking material permitsexcess fluid to be removed from tissue surrounding a surgical site;placing the arthroscopic instrument inside of the extravasationminimization device; and performing an arthroscopic surgical procedure.7. The method of claim 6 further comprising providing a vacuum source influid communication with the manifold.
 8. The method of claim 6 furthercomprising providing a sink in fluid communication with the manifold.